Validation Engineer
On-siteMinneapolis, Minnesota, United States
Job Summary
Execute facility, utility, and equipment qualification activities including IQ, OQ, and PQ protocols for OTC pharmaceutical and personal care products. Support process validation, cleaning validation studies, and computer system validation aligned with cGMP, FDA, and regulatory data integrity requirements. Develop, review, and maintain validation documentation such as SOPs, protocols, and batch records while collaborating with Quality Assurance, Production, and Engineering teams. Manage assigned validation projects to ensure timely completion, prepare technical reports for leadership, and participate in audits to address observations and implement corrective actions. Requires a Bachelor's degree in a scientific discipline and three years of pharmaceutical validation experience.
Required Qualifications
- Bachelors degree in chemistry, physical sciences, engineering, or a related scientific discipline.
- Minimum of three years of experience in pharmaceutical and or personal care validation, including experience in Rx or OTC manufacturing environments.
- Strong knowledge of cGMP regulations, FDA requirements, and OTC compliance standards.
- Demonstrated experience with facility, utility, and equipment qualification requirements.
- Working knowledge of process validation, process performance qualification, and cleaning validation principles.
- Experience performing computer system validation in regulated manufacturing environments.
- Proven ability to develop, execute, and maintain compliant validation systems and documentation.
- Strong technical writing, record keeping, and data analysis skills.
- Excellent communication skills with the ability to collaborate effectively across functional teams and organizational levels.
Desired Qualifications
- Lean Six Sigma certification, Green Belt or higher.
- Experience supporting new product introductions and scale up activities in OTC or personal care manufacturing.
- Familiarity with risk management tools and methodologies used in regulated environments.
- Demonstrated leadership ability in managing validation projects and cross functional initiatives.
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